Is There an Association Between Quadriceps Strength and Different Markers of Fragility in Patients With Cirrhosis?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Isometric quadriceps strength
研究概览
简要总结
Physical frailty and malnutrition are important factors in morbidity and mortality in patients with cirrhosis. No study has assessed the validity of Liver Frailty Index (LFI) against reference measures such as maximal lower limb strength.
Main objective: To assess the association between LFI score and isometric maximal lower limb strength (quadriceps) in patients with cirrhosis.
详细描述
Secondary objective: compare the different strength parameters of patients with cirrhosis (strength endurance, rate of strength development) with healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •with a diagnosis of liver cirrhosis (regardless of cirrhosis stage and etiology)
- •under the care of a physician practising in the University Hospital Estaing in Clermont-Ferrand
- •affiliated to the french social security system
排除标准
- •with hepatocellular carcinoma
- •with HIV infection
- •with hepatic encephalopathy grade ≥ 2
- •with cognitive dysfunction
- •with contraindication for physical activity
- •with knee pain/knee disorders
- •pregnant or breastfeeding
- •under protective supervision (guardianship, curatorship, protection of the court)
- •Inclusion Criteria for healthy volonteers:
- •male subjects aged 52 to 62
- •female subjects aged 42 to 60
- •BMI between 20 and 30 kg/m2
- •no musculoskeletal problems limiting physical activity
- •level of physical activity < 3 hours per week
- •affiliated to the french social security system
- •Exclusion Criteria for healthy volonteers:
- •medical or surgical history deemed incompatible with the trial by the investigator
- •simultaneous participation in a trial involving a drug or medical device, or period of exclusion from such a trial
- •participants protected by law (under guardianship, conservatorship, or protection of the court)
研究组 & 干预措施
Patients with cirrhosis (45)
Same assessments for all patients (cirrhosis)
干预措施: Frailty assessment (Other)
Healthy volunteers (15 subjects)
Same assessments for all healthy volunteers
干预措施: Frailty assessments (Other)
结局指标
主要结局
Isometric quadriceps strength
时间窗: once, at inclusion
Isometric quadriceps strength (N.m) will be assessed 3 times with 30 second rest between each try. The dominant leg of each participant will be assessed, a standardised warm-up will be conducted to have effective results.
次要结局
- Malnutrition: Mini Nutritional Assessment (MNA))(once, at inclusion)
- Body composition by circumference and triceps skinfold(once, at inclusion)
- Frailty by LFI(once, at inclusion)
- Frailty by Short Physical Performance Battery (SPPB)(once, at inclusion)
- Malnutrition: Royal Free Hospital-Nutritional Prioritizing Tool (RFH-NPT)(once, at inclusion)
- Muscle cramps by Cramp questionnaire(once, at inclusion)